HL7 FHIR Implementation Guide: Example IG Release 1 - US Realm | STU1
1.0.0 - STU1

HL7 FHIR Implementation Guide: Example IG Release 1 - US Realm | STU1 - Local Development build (v1.0.0). See the Directory of published versions

Logical Model: IDMP11615Investigational

Official URL: http://example.com/fhir/example/StructureDefinition/InvestigationalMedicinalProduct Version: 1.0.0
Active as of 2022-09-27 Responsible: My Organization Realm: International flag Computable Name: IDMP11615Investigational

ISO 11615 Investigational Medicinal Product

Usage:

  • This Logical Model Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Base

Summary

Mandatory: 0 element (296 nested mandatory elements)

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraintsdoco
.. InvestigationalMedicinalProduct 0..*
... IMPID 1..1IdentifierThe identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2)
... CombinedPharmaceuticalDoseForm 0..1CodeableConceptThe combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3)
... SponsorProductCode 0..1stringThe product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4)
... PaediatricUseIndicator 0..1CodeableConceptIf the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6)
... ClinicalTrialStatus 0..1CodeableConceptThe status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7)
... OrphanDesignationStatus 0..1CodeableConceptSee 9.2.2.2.7 . (11.3.2.2.8)
... AttachedDocument 1..*BackboneElement11.3.2.6
.... Identifier 1..1IdentifierThe reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)
.... EffectiveDate 1..1dateThe date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)
.... Type 1..1CodeableConceptThe type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)
.... Content 1..1base64BinaryThe actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)
.... Language 0..1CodeableConceptThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)
.... MediaType 0..1CodeableConceptThis attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)
.... VersionNumber 0..1stringThis is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)
.... VersionSetIdentifier 0..1IdentifierThis is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)
... ClinicalTrialAuthorisation 1..*BackboneElement11.4.2.2
.... RegistrationNumber 1..1IdentifierThe registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2)
.... InvestigationCode 1..1stringThe code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3)
.... Country 1..*CodeableConceptThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4)
.... ProtocolNumber 1..1IdentifierThe number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5)
.... AuthorisationDate 1..1dateThe date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6)
.... AnticipatedEndDate 1..1dateThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7)
.... LocalClinicalTrialAuthorisation 0..*BackboneElement11.4.2.3
..... LocalClinicalTrialRegistrationNumber 1..1IdentifierThe registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2)
..... LocalInvestigationCode 1..1stringThe “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3)
..... Jurisdiction 1..*CodeableConceptThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4)
..... LocalAuthorisationDate 1..1dateThe date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5)
..... LocalAnticipatedEndDate 1..1dateThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6)
.... MedicinesRegulatoryAgency_Organisation 1..1BackboneElement9.3.2.5
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... Sponsor_Organisation 1..1BackboneElement11.4.2.4
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... SME 0..1BackboneElement9.3.2.4
...... SMEFlag 1..1booleanThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
...... Size 0..1CodeableConceptThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
...... SMENumber 0..1IdentifierThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
...... StatusDate 0..1dateThis is the date when the SME status was granted. (9.3.2.4.4)
... Contraindication 0..*BackboneElement9.9.2.3
.... ContraindicationsText 1..1stringThe text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)
.... ContraindicationsAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)
.... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)
.... Comorbidity 0..*CodeableConceptThe comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)
.... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
..... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
..... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
.... PopulationSpecifics 0..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
.... TherapeuticIndication 0..*BackboneElement9.9.2.2
..... IndicationText 1..1stringThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
..... IndicationAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
..... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
..... Comorbidity 0..*CodeableConceptIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
..... IntendedEffect 0..1CodeableConceptThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
..... Timing-Duration 0..1QuantityIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
..... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
...... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
...... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
..... PopulationSpecifics 1..*BackboneElement9.9.2.5
...... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
...... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
...... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
...... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
...... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
...... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
..... UndesirableEffects 0..*BackboneElement9.9.2.4
...... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
...... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
...... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
...... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
...... PopulationSpecifics 0..*BackboneElement9.9.2.5
....... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
....... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
....... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
....... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
....... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
....... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
... Header 1..1BackboneElement11.3.2.5
.... Identifier 1..1IdentifierThis attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)
.... EffectiveDate 1..1dateThe date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)
.... Language 0..1CodeableConceptThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)
.... VersionNumber 0..1stringThis is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)
.... VersionSetIdentifier 0..1IdentifierThis is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)
... Interactions 0..*BackboneElement9.9.2.7
.... InteractionsText 1..1stringThe text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)
.... Interactant 0..*CodeableConceptThis element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)
.... InteractionsType 0..1CodeableConceptThe type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)
.... InteractionsEffect 0..1CodeableConceptThe effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)
.... InteractionsIncidence 0..1CodeableConceptThe incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)
.... ManagementActions 0..1CodeableConceptThe actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)
... InvestigationalMedicinalProductName 1..1BackboneElement11.3.2.8
.... FullName 0..1stringThe full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1)
.... Code 0..1stringThe Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2)
.... InventedNamePart 0..*stringThe invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)
.... ScientificNamePart 0..*stringThe scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)
.... StrengthPart 0..*stringThe strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)
.... PharmaceuticalDoseFormPart 0..*stringThe pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)
.... FormulationPart 0..*stringThe formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)
.... IntendedUsePart 0..*stringThe intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)
.... TargetPopulationPart 0..*stringThe target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)
.... ContainerOrPackPart 0..*stringThe container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)
.... DevicePart 0..*stringThe device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)
.... TrademarkOrCompanyNamePart 0..*stringThe trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)
.... Time-PeriodPart 0..*stringThe time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)
.... FlavourPart 0..*stringThe flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)
.... DelimiterPart 0..*stringA delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)
.... Country-Language 1..*BackboneElement9.2.2.9
..... Country 1..1CodeableConceptThe country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)
..... Jurisdiction 0..1CodeableConceptThe jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)
..... Language 1..1CodeableConceptThe language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)
... InvestigationalPackagedMedicinalProduct 0..*BackboneElement11.2.7
.... IPCID 1..1IdentifierThis is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)
.... PackageDescription 1..1stringA textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)
.... BatchIdentifier 0..*BackboneElement9.6.2.8
..... BAID1 1..1IdentifierThe BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)
..... BAID2 0..1IdentifierThe BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)
..... ExpirationDate 1..1dateThis is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)
.... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
...... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
...... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
...... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
...... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... PackageItem_Container 1..*BackboneElement9.6.2.3
..... PackageItem_ContainerType 1..1CodeableConceptThe package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)
..... PackageItem_ContainerQuantity 1..1QuantityThe quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)
..... Material 1..*CodeableConceptThe material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)
..... AlternateMaterial 0..*CodeableConceptThe alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)
..... DataCarrierIdentifier 0..*BackboneElement9.6.2.4
...... CodeSystem 1..1CodeableConceptThe data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)
...... Value 1..1CodeableConceptThe individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)
..... Device 0..*BackboneElement9.6.2.12
...... DeviceType 1..1CodeableConceptThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
...... DeviceTradeName 0..1stringThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
...... DeviceQuantity 1..1QuantityThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
...... DeviceListingNumber 0..1stringThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
...... DeviceIdentifier 0..1IdentifierA unique device identifier needs to be specified. (9.6.2.12.6)
...... ModelNumber 0..1stringThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
...... SterilityIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
...... SterilisationRequirementIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
...... DeviceUsage 0..1CodeableConceptThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
...... DeviceBatchIdentifier 0..*BackboneElement11.12
....... BatchNumber 1..1stringWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
....... ExpirationDate 1..1dateWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
...... DeviceMaterial 0..*BackboneElement9.6.2.13
....... Substance 1..1CodeableConceptThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
....... Alternate 0..1booleanThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
....... AllergenicIndicator 0..1booleanThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
...... DeviceNomenclature 0..*BackboneElement11.11
....... CodeSystem 1..1CodeableConceptThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
....... Value 1..1CodeableConceptThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
...... Manufacturer-Establishment_Organisation 0..1BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... OtherCharacteristics 0..*BackboneElement9.6.2.22
....... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
....... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
...... ShelfLife-Storage 0..*BackboneElement9.6.2.11
....... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
....... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
....... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
..... ManufacturedItem 0..*BackboneElement9.6.2.20
...... ManufacturedDoseForm 1..1CodeableConceptThis describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)
...... UnitOfPresentation 0..1CodeableConceptThis specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)
...... ManufacturedItemQuantity 1..1QuantityThe quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)
...... Ingredient 1..*BackboneElement11.2.9
....... IngredientRole 1..1CodeableConceptThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
....... AllergenicIndicator 0..1booleanThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
....... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
........ Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
......... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
......... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
......... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
......... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
.......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
.......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
.......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
.......... Contact 1..*BackboneElement9.4.2.4
........... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
.......... OtherLocations 0..*BackboneElement9.4.2.3
........... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... SpecifiedSubstance 0..*BackboneElement9.7.2.4
........ SpecifiedSubstance 1..1CodeableConceptWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
........ SpecifiedSubstanceGroup 1..1CodeableConceptThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
........ Strength 0..*BackboneElement9.7.2.5
......... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
......... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
......... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
......... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
......... ReferenceStrength 0..*BackboneElement9.7.2.6
.......... ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
.......... ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
.......... ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
.......... ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
.......... ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
....... Substance 0..1BackboneElement9.7.2.3
........ Substance 1..1CodeableConceptA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
........ Strength 1..*BackboneElement9.7.2.5
......... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
......... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
......... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
......... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
......... ReferenceStrength 0..*BackboneElement9.7.2.6
.......... ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
.......... ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
.......... ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
.......... ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
.......... ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
...... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... OtherCharacteristics 0..*BackboneElement9.6.2.22
....... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
....... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... OtherCharacteristics 0..*BackboneElement9.6.2.22
...... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
...... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
..... Package_Component 0..*BackboneElement9.6.2.9
...... ComponentType 1..1CodeableConceptThe type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)
...... ComponentMaterial 0..*CodeableConceptThe material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)
...... ComponentAlternateMaterial 0..*CodeableConceptAlternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)
...... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... PhysicalCharacteristics 0..1BackboneElement11.13
...... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
...... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
...... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
...... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
...... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
...... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
...... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
...... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
...... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
...... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
...... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... ShelfLife-Storage 0..*BackboneElement9.6.2.11
...... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
...... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
...... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
.... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
.... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
.... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
.... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
.... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
.... Contact 1..*BackboneElement9.4.2.4
..... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
..... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
..... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
.... OtherLocations 0..*BackboneElement9.4.2.3
..... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
..... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
..... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
..... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
..... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
..... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
..... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
..... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
... OrphanDesignation 0..*BackboneElement9.2.2.3
.... OrphanIndicationType 1..1CodeableConceptThis attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)
.... OrphanProcedureNumber 0..1IdentifierThis attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)
.... OrphanDesignationAuthorisationStatus 1..1CodeableConceptThis attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)
.... OrphanDesignationAuthorisationDate 0..1dateThis attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)
.... OrphanDesignationNumber 0..1IdentifierThis field is to indicate the orphan designation decision number. (9.2.2.3.6)
... PharmaceuticalProduct 1..*BackboneElement11.7.2
.... AdministrableDoseForm 1..1CodeableConceptThis shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)
.... UnitOfPresentation 0..1CodeableConceptThe unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)
.... Device 0..*BackboneElement9.6.2.12
..... DeviceType 1..1CodeableConceptThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
..... DeviceTradeName 0..1stringThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
..... DeviceQuantity 1..1QuantityThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
..... DeviceListingNumber 0..1stringThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
..... DeviceIdentifier 0..1IdentifierA unique device identifier needs to be specified. (9.6.2.12.6)
..... ModelNumber 0..1stringThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
..... SterilityIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
..... SterilisationRequirementIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
..... DeviceUsage 0..1CodeableConceptThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
..... DeviceBatchIdentifier 0..*BackboneElement11.12
...... BatchNumber 1..1stringWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
...... ExpirationDate 1..1dateWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
..... DeviceMaterial 0..*BackboneElement9.6.2.13
...... Substance 1..1CodeableConceptThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
...... Alternate 0..1booleanThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
...... AllergenicIndicator 0..1booleanThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
..... DeviceNomenclature 0..*BackboneElement11.11
...... CodeSystem 1..1CodeableConceptThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
...... Value 1..1CodeableConceptThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
..... Manufacturer-Establishment_Organisation 0..1BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... OtherCharacteristics 0..*BackboneElement9.6.2.22
...... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
...... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
..... PhysicalCharacteristics 0..1BackboneElement11.13
...... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
...... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
...... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
...... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
...... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
...... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
...... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
...... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
...... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
...... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
...... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... ShelfLife-Storage 0..*BackboneElement9.6.2.11
...... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
...... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
...... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
.... DosingAndRouteOfAdministration 1..*BackboneElement11.7.3
..... RouteOfAdministration 1..1CodeableConcept (11.7.3.0)
..... FirstDoseInHumans 0..1QuantityThe first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2)
..... MaximumSingleDose 0..1QuantityThe maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3)
..... MaximumDosePerDay 0..1QuantityThe maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4)
..... MaximumDosePerTreatmentPeriod 0..1RatioThe maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5)
..... MaximumTreatmentPeriod 0..1QuantityThe maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6)
.... Ingredient 1..*BackboneElement11.2.9
..... IngredientRole 1..1CodeableConceptThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
..... AllergenicIndicator 0..1booleanThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
..... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... SpecifiedSubstance 0..*BackboneElement9.7.2.4
...... SpecifiedSubstance 1..1CodeableConceptWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
...... SpecifiedSubstanceGroup 1..1CodeableConceptThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
...... Strength 0..*BackboneElement9.7.2.5
....... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
....... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
....... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
....... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
....... ReferenceStrength 0..*BackboneElement9.7.2.6
........ ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
........ ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
........ ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
........ ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
........ ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
..... Substance 0..1BackboneElement9.7.2.3
...... Substance 1..1CodeableConceptA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
...... Strength 1..*BackboneElement9.7.2.5
....... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
....... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
....... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
....... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
....... ReferenceStrength 0..*BackboneElement9.7.2.6
........ ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
........ ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
........ ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
........ ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
........ ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
.... PharmaceuticalProductCharacteristics 0..*BackboneElement9.8.2.4
..... CodeSystem 1..1CodeableConceptThe code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)
..... Value 1..1CodeableConceptThe individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)
..... Status 0..1CodeableConceptThe status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)
.... PhPIDSet 1..*BackboneElement9.8.2.6
..... PhPIDIdentifierSets 1..1IdentifierThis class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)
... ProductClassification 0..*BackboneElement11.3.2.7
.... CodeSystem 1..1CodeableConceptThe Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)
.... Value 1..1CodeableConceptThe individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)
... ProductCross-Reference 0..*BackboneElement11.3.2.4
.... I_MPIDCross-Reference 1..1IdentifierThis is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)
.... ReferencedProductType 0..1CodeableConceptThis attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)
... TherapeuticIndication 1..*BackboneElement9.9.2.2
.... IndicationText 1..1stringThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
.... IndicationAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
.... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
.... Comorbidity 0..*CodeableConceptIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
.... IntendedEffect 0..1CodeableConceptThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
.... Timing-Duration 0..1QuantityIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
.... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
..... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
..... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
.... PopulationSpecifics 1..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
.... UndesirableEffects 0..*BackboneElement9.9.2.4
..... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
..... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
..... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
..... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
..... PopulationSpecifics 0..*BackboneElement9.9.2.5
...... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
...... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
...... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
...... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
...... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
...... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
... UndesirableEffects 0..*BackboneElement9.9.2.4
.... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
.... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
.... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
.... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
.... PopulationSpecifics 0..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. InvestigationalMedicinalProduct 0..*
... IMPID 1..1IdentifierThe identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2)
... CombinedPharmaceuticalDoseForm 0..1CodeableConceptThe combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3)
... SponsorProductCode 0..1stringThe product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4)
... PaediatricUseIndicator 0..1CodeableConceptIf the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6)
... ClinicalTrialStatus 0..1CodeableConceptThe status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7)
... OrphanDesignationStatus 0..1CodeableConceptSee 9.2.2.2.7 . (11.3.2.2.8)
... AttachedDocument 1..*BackboneElement11.3.2.6
.... Identifier 1..1IdentifierThe reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)
.... EffectiveDate 1..1dateThe date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)
.... Type 1..1CodeableConceptThe type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)
.... Content 1..1base64BinaryThe actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)
.... Language 0..1CodeableConceptThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)
.... MediaType 0..1CodeableConceptThis attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)
.... VersionNumber 0..1stringThis is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)
.... VersionSetIdentifier 0..1IdentifierThis is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)
... ClinicalTrialAuthorisation 1..*BackboneElement11.4.2.2
.... RegistrationNumber 1..1IdentifierThe registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2)
.... InvestigationCode 1..1stringThe code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3)
.... Country 1..*CodeableConceptThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4)
.... ProtocolNumber 1..1IdentifierThe number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5)
.... AuthorisationDate 1..1dateThe date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6)
.... AnticipatedEndDate 1..1dateThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7)
.... LocalClinicalTrialAuthorisation 0..*BackboneElement11.4.2.3
..... LocalClinicalTrialRegistrationNumber 1..1IdentifierThe registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2)
..... LocalInvestigationCode 1..1stringThe “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3)
..... Jurisdiction 1..*CodeableConceptThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4)
..... LocalAuthorisationDate 1..1dateThe date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5)
..... LocalAnticipatedEndDate 1..1dateThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6)
.... MedicinesRegulatoryAgency_Organisation 1..1BackboneElement9.3.2.5
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... Sponsor_Organisation 1..1BackboneElement11.4.2.4
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... SME 0..1BackboneElement9.3.2.4
...... SMEFlag 1..1booleanThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
...... Size 0..1CodeableConceptThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
...... SMENumber 0..1IdentifierThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
...... StatusDate 0..1dateThis is the date when the SME status was granted. (9.3.2.4.4)
... Contraindication 0..*BackboneElement9.9.2.3
.... ContraindicationsText 1..1stringThe text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)
.... ContraindicationsAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)
.... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)
.... Comorbidity 0..*CodeableConceptThe comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)
.... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
..... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
..... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
.... PopulationSpecifics 0..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
.... TherapeuticIndication 0..*BackboneElement9.9.2.2
..... IndicationText 1..1stringThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
..... IndicationAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
..... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
..... Comorbidity 0..*CodeableConceptIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
..... IntendedEffect 0..1CodeableConceptThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
..... Timing-Duration 0..1QuantityIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
..... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
...... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
...... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
..... PopulationSpecifics 1..*BackboneElement9.9.2.5
...... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
...... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
...... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
...... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
...... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
...... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
..... UndesirableEffects 0..*BackboneElement9.9.2.4
...... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
...... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
...... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
...... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
...... PopulationSpecifics 0..*BackboneElement9.9.2.5
....... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
....... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
....... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
....... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
....... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
....... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
... Header 1..1BackboneElement11.3.2.5
.... Identifier 1..1IdentifierThis attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)
.... EffectiveDate 1..1dateThe date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)
.... Language 0..1CodeableConceptThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)
.... VersionNumber 0..1stringThis is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)
.... VersionSetIdentifier 0..1IdentifierThis is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)
... Interactions 0..*BackboneElement9.9.2.7
.... InteractionsText 1..1stringThe text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)
.... Interactant 0..*CodeableConceptThis element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)
.... InteractionsType 0..1CodeableConceptThe type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)
.... InteractionsEffect 0..1CodeableConceptThe effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)
.... InteractionsIncidence 0..1CodeableConceptThe incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)
.... ManagementActions 0..1CodeableConceptThe actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)
... InvestigationalMedicinalProductName 1..1BackboneElement11.3.2.8
.... FullName 0..1stringThe full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1)
.... Code 0..1stringThe Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2)
.... InventedNamePart 0..*stringThe invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)
.... ScientificNamePart 0..*stringThe scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)
.... StrengthPart 0..*stringThe strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)
.... PharmaceuticalDoseFormPart 0..*stringThe pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)
.... FormulationPart 0..*stringThe formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)
.... IntendedUsePart 0..*stringThe intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)
.... TargetPopulationPart 0..*stringThe target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)
.... ContainerOrPackPart 0..*stringThe container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)
.... DevicePart 0..*stringThe device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)
.... TrademarkOrCompanyNamePart 0..*stringThe trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)
.... Time-PeriodPart 0..*stringThe time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)
.... FlavourPart 0..*stringThe flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)
.... DelimiterPart 0..*stringA delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)
.... Country-Language 1..*BackboneElement9.2.2.9
..... Country 1..1CodeableConceptThe country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)
..... Jurisdiction 0..1CodeableConceptThe jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)
..... Language 1..1CodeableConceptThe language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)
... InvestigationalPackagedMedicinalProduct 0..*BackboneElement11.2.7
.... IPCID 1..1IdentifierThis is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)
.... PackageDescription 1..1stringA textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)
.... BatchIdentifier 0..*BackboneElement9.6.2.8
..... BAID1 1..1IdentifierThe BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)
..... BAID2 0..1IdentifierThe BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)
..... ExpirationDate 1..1dateThis is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)
.... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
...... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
...... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
...... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
...... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... PackageItem_Container 1..*BackboneElement9.6.2.3
..... PackageItem_ContainerType 1..1CodeableConceptThe package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)
..... PackageItem_ContainerQuantity 1..1QuantityThe quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)
..... Material 1..*CodeableConceptThe material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)
..... AlternateMaterial 0..*CodeableConceptThe alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)
..... DataCarrierIdentifier 0..*BackboneElement9.6.2.4
...... CodeSystem 1..1CodeableConceptThe data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)
...... Value 1..1CodeableConceptThe individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)
..... Device 0..*BackboneElement9.6.2.12
...... DeviceType 1..1CodeableConceptThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
...... DeviceTradeName 0..1stringThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
...... DeviceQuantity 1..1QuantityThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
...... DeviceListingNumber 0..1stringThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
...... DeviceIdentifier 0..1IdentifierA unique device identifier needs to be specified. (9.6.2.12.6)
...... ModelNumber 0..1stringThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
...... SterilityIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
...... SterilisationRequirementIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
...... DeviceUsage 0..1CodeableConceptThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
...... DeviceBatchIdentifier 0..*BackboneElement11.12
....... BatchNumber 1..1stringWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
....... ExpirationDate 1..1dateWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
...... DeviceMaterial 0..*BackboneElement9.6.2.13
....... Substance 1..1CodeableConceptThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
....... Alternate 0..1booleanThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
....... AllergenicIndicator 0..1booleanThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
...... DeviceNomenclature 0..*BackboneElement11.11
....... CodeSystem 1..1CodeableConceptThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
....... Value 1..1CodeableConceptThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
...... Manufacturer-Establishment_Organisation 0..1BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... OtherCharacteristics 0..*BackboneElement9.6.2.22
....... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
....... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
...... ShelfLife-Storage 0..*BackboneElement9.6.2.11
....... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
....... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
....... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
..... ManufacturedItem 0..*BackboneElement9.6.2.20
...... ManufacturedDoseForm 1..1CodeableConceptThis describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)
...... UnitOfPresentation 0..1CodeableConceptThis specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)
...... ManufacturedItemQuantity 1..1QuantityThe quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)
...... Ingredient 1..*BackboneElement11.2.9
....... IngredientRole 1..1CodeableConceptThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
....... AllergenicIndicator 0..1booleanThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
....... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
........ Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
......... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
......... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
......... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
......... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
.......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
.......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
.......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
.......... Contact 1..*BackboneElement9.4.2.4
........... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
.......... OtherLocations 0..*BackboneElement9.4.2.3
........... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... SpecifiedSubstance 0..*BackboneElement9.7.2.4
........ SpecifiedSubstance 1..1CodeableConceptWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
........ SpecifiedSubstanceGroup 1..1CodeableConceptThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
........ Strength 0..*BackboneElement9.7.2.5
......... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
......... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
......... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
......... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
......... ReferenceStrength 0..*BackboneElement9.7.2.6
.......... ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
.......... ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
.......... ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
.......... ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
.......... ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
....... Substance 0..1BackboneElement9.7.2.3
........ Substance 1..1CodeableConceptA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
........ Strength 1..*BackboneElement9.7.2.5
......... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
......... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
......... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
......... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
......... ReferenceStrength 0..*BackboneElement9.7.2.6
.......... ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
.......... ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
.......... ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
.......... ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
.......... ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
...... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... OtherCharacteristics 0..*BackboneElement9.6.2.22
....... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
....... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... OtherCharacteristics 0..*BackboneElement9.6.2.22
...... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
...... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
..... Package_Component 0..*BackboneElement9.6.2.9
...... ComponentType 1..1CodeableConceptThe type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)
...... ComponentMaterial 0..*CodeableConceptThe material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)
...... ComponentAlternateMaterial 0..*CodeableConceptAlternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)
...... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... PhysicalCharacteristics 0..1BackboneElement11.13
...... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
...... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
...... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
...... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
...... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
...... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
...... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
...... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
...... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
...... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
...... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... ShelfLife-Storage 0..*BackboneElement9.6.2.11
...... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
...... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
...... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
.... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
.... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
.... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
.... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
.... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
.... Contact 1..*BackboneElement9.4.2.4
..... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
..... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
..... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
.... OtherLocations 0..*BackboneElement9.4.2.3
..... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
..... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
..... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
..... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
..... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
..... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
..... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
..... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
... OrphanDesignation 0..*BackboneElement9.2.2.3
.... OrphanIndicationType 1..1CodeableConceptThis attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)
.... OrphanProcedureNumber 0..1IdentifierThis attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)
.... OrphanDesignationAuthorisationStatus 1..1CodeableConceptThis attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)
.... OrphanDesignationAuthorisationDate 0..1dateThis attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)
.... OrphanDesignationNumber 0..1IdentifierThis field is to indicate the orphan designation decision number. (9.2.2.3.6)
... PharmaceuticalProduct 1..*BackboneElement11.7.2
.... AdministrableDoseForm 1..1CodeableConceptThis shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)
.... UnitOfPresentation 0..1CodeableConceptThe unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)
.... Device 0..*BackboneElement9.6.2.12
..... DeviceType 1..1CodeableConceptThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
..... DeviceTradeName 0..1stringThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
..... DeviceQuantity 1..1QuantityThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
..... DeviceListingNumber 0..1stringThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
..... DeviceIdentifier 0..1IdentifierA unique device identifier needs to be specified. (9.6.2.12.6)
..... ModelNumber 0..1stringThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
..... SterilityIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
..... SterilisationRequirementIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
..... DeviceUsage 0..1CodeableConceptThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
..... DeviceBatchIdentifier 0..*BackboneElement11.12
...... BatchNumber 1..1stringWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
...... ExpirationDate 1..1dateWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
..... DeviceMaterial 0..*BackboneElement9.6.2.13
...... Substance 1..1CodeableConceptThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
...... Alternate 0..1booleanThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
...... AllergenicIndicator 0..1booleanThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
..... DeviceNomenclature 0..*BackboneElement11.11
...... CodeSystem 1..1CodeableConceptThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
...... Value 1..1CodeableConceptThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
..... Manufacturer-Establishment_Organisation 0..1BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... OtherCharacteristics 0..*BackboneElement9.6.2.22
...... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
...... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
..... PhysicalCharacteristics 0..1BackboneElement11.13
...... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
...... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
...... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
...... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
...... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
...... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
...... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
...... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
...... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
...... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
...... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... ShelfLife-Storage 0..*BackboneElement9.6.2.11
...... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
...... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
...... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
.... DosingAndRouteOfAdministration 1..*BackboneElement11.7.3
..... RouteOfAdministration 1..1CodeableConcept (11.7.3.0)
..... FirstDoseInHumans 0..1QuantityThe first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2)
..... MaximumSingleDose 0..1QuantityThe maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3)
..... MaximumDosePerDay 0..1QuantityThe maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4)
..... MaximumDosePerTreatmentPeriod 0..1RatioThe maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5)
..... MaximumTreatmentPeriod 0..1QuantityThe maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6)
.... Ingredient 1..*BackboneElement11.2.9
..... IngredientRole 1..1CodeableConceptThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
..... AllergenicIndicator 0..1booleanThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
..... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... SpecifiedSubstance 0..*BackboneElement9.7.2.4
...... SpecifiedSubstance 1..1CodeableConceptWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
...... SpecifiedSubstanceGroup 1..1CodeableConceptThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
...... Strength 0..*BackboneElement9.7.2.5
....... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
....... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
....... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
....... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
....... ReferenceStrength 0..*BackboneElement9.7.2.6
........ ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
........ ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
........ ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
........ ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
........ ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
..... Substance 0..1BackboneElement9.7.2.3
...... Substance 1..1CodeableConceptA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
...... Strength 1..*BackboneElement9.7.2.5
....... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
....... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
....... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
....... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
....... ReferenceStrength 0..*BackboneElement9.7.2.6
........ ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
........ ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
........ ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
........ ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
........ ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
.... PharmaceuticalProductCharacteristics 0..*BackboneElement9.8.2.4
..... CodeSystem 1..1CodeableConceptThe code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)
..... Value 1..1CodeableConceptThe individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)
..... Status 0..1CodeableConceptThe status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)
.... PhPIDSet 1..*BackboneElement9.8.2.6
..... PhPIDIdentifierSets 1..1IdentifierThis class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)
... ProductClassification 0..*BackboneElement11.3.2.7
.... CodeSystem 1..1CodeableConceptThe Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)
.... Value 1..1CodeableConceptThe individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)
... ProductCross-Reference 0..*BackboneElement11.3.2.4
.... I_MPIDCross-Reference 1..1IdentifierThis is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)
.... ReferencedProductType 0..1CodeableConceptThis attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)
... TherapeuticIndication 1..*BackboneElement9.9.2.2
.... IndicationText 1..1stringThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
.... IndicationAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
.... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
.... Comorbidity 0..*CodeableConceptIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
.... IntendedEffect 0..1CodeableConceptThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
.... Timing-Duration 0..1QuantityIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
.... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
..... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
..... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
.... PopulationSpecifics 1..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
.... UndesirableEffects 0..*BackboneElement9.9.2.4
..... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
..... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
..... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
..... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
..... PopulationSpecifics 0..*BackboneElement9.9.2.5
...... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
...... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
...... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
...... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
...... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
...... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
... UndesirableEffects 0..*BackboneElement9.9.2.4
.... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
.... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
.... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
.... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
.... PopulationSpecifics 0..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

doco Documentation for this format

This structure is derived from Base

Summary

Mandatory: 0 element (296 nested mandatory elements)

Differential View

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraintsdoco
.. InvestigationalMedicinalProduct 0..*
... IMPID 1..1IdentifierThe identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2)
... CombinedPharmaceuticalDoseForm 0..1CodeableConceptThe combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3)
... SponsorProductCode 0..1stringThe product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4)
... PaediatricUseIndicator 0..1CodeableConceptIf the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6)
... ClinicalTrialStatus 0..1CodeableConceptThe status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7)
... OrphanDesignationStatus 0..1CodeableConceptSee 9.2.2.2.7 . (11.3.2.2.8)
... AttachedDocument 1..*BackboneElement11.3.2.6
.... Identifier 1..1IdentifierThe reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)
.... EffectiveDate 1..1dateThe date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)
.... Type 1..1CodeableConceptThe type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)
.... Content 1..1base64BinaryThe actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)
.... Language 0..1CodeableConceptThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)
.... MediaType 0..1CodeableConceptThis attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)
.... VersionNumber 0..1stringThis is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)
.... VersionSetIdentifier 0..1IdentifierThis is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)
... ClinicalTrialAuthorisation 1..*BackboneElement11.4.2.2
.... RegistrationNumber 1..1IdentifierThe registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2)
.... InvestigationCode 1..1stringThe code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3)
.... Country 1..*CodeableConceptThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4)
.... ProtocolNumber 1..1IdentifierThe number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5)
.... AuthorisationDate 1..1dateThe date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6)
.... AnticipatedEndDate 1..1dateThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7)
.... LocalClinicalTrialAuthorisation 0..*BackboneElement11.4.2.3
..... LocalClinicalTrialRegistrationNumber 1..1IdentifierThe registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2)
..... LocalInvestigationCode 1..1stringThe “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3)
..... Jurisdiction 1..*CodeableConceptThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4)
..... LocalAuthorisationDate 1..1dateThe date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5)
..... LocalAnticipatedEndDate 1..1dateThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6)
.... MedicinesRegulatoryAgency_Organisation 1..1BackboneElement9.3.2.5
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... Sponsor_Organisation 1..1BackboneElement11.4.2.4
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... SME 0..1BackboneElement9.3.2.4
...... SMEFlag 1..1booleanThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
...... Size 0..1CodeableConceptThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
...... SMENumber 0..1IdentifierThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
...... StatusDate 0..1dateThis is the date when the SME status was granted. (9.3.2.4.4)
... Contraindication 0..*BackboneElement9.9.2.3
.... ContraindicationsText 1..1stringThe text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)
.... ContraindicationsAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)
.... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)
.... Comorbidity 0..*CodeableConceptThe comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)
.... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
..... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
..... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
.... PopulationSpecifics 0..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
.... TherapeuticIndication 0..*BackboneElement9.9.2.2
..... IndicationText 1..1stringThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
..... IndicationAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
..... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
..... Comorbidity 0..*CodeableConceptIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
..... IntendedEffect 0..1CodeableConceptThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
..... Timing-Duration 0..1QuantityIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
..... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
...... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
...... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
..... PopulationSpecifics 1..*BackboneElement9.9.2.5
...... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
...... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
...... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
...... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
...... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
...... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
..... UndesirableEffects 0..*BackboneElement9.9.2.4
...... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
...... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
...... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
...... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
...... PopulationSpecifics 0..*BackboneElement9.9.2.5
....... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
....... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
....... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
....... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
....... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
....... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
... Header 1..1BackboneElement11.3.2.5
.... Identifier 1..1IdentifierThis attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)
.... EffectiveDate 1..1dateThe date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)
.... Language 0..1CodeableConceptThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)
.... VersionNumber 0..1stringThis is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)
.... VersionSetIdentifier 0..1IdentifierThis is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)
... Interactions 0..*BackboneElement9.9.2.7
.... InteractionsText 1..1stringThe text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)
.... Interactant 0..*CodeableConceptThis element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)
.... InteractionsType 0..1CodeableConceptThe type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)
.... InteractionsEffect 0..1CodeableConceptThe effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)
.... InteractionsIncidence 0..1CodeableConceptThe incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)
.... ManagementActions 0..1CodeableConceptThe actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)
... InvestigationalMedicinalProductName 1..1BackboneElement11.3.2.8
.... FullName 0..1stringThe full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1)
.... Code 0..1stringThe Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2)
.... InventedNamePart 0..*stringThe invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)
.... ScientificNamePart 0..*stringThe scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)
.... StrengthPart 0..*stringThe strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)
.... PharmaceuticalDoseFormPart 0..*stringThe pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)
.... FormulationPart 0..*stringThe formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)
.... IntendedUsePart 0..*stringThe intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)
.... TargetPopulationPart 0..*stringThe target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)
.... ContainerOrPackPart 0..*stringThe container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)
.... DevicePart 0..*stringThe device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)
.... TrademarkOrCompanyNamePart 0..*stringThe trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)
.... Time-PeriodPart 0..*stringThe time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)
.... FlavourPart 0..*stringThe flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)
.... DelimiterPart 0..*stringA delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)
.... Country-Language 1..*BackboneElement9.2.2.9
..... Country 1..1CodeableConceptThe country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)
..... Jurisdiction 0..1CodeableConceptThe jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)
..... Language 1..1CodeableConceptThe language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)
... InvestigationalPackagedMedicinalProduct 0..*BackboneElement11.2.7
.... IPCID 1..1IdentifierThis is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)
.... PackageDescription 1..1stringA textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)
.... BatchIdentifier 0..*BackboneElement9.6.2.8
..... BAID1 1..1IdentifierThe BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)
..... BAID2 0..1IdentifierThe BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)
..... ExpirationDate 1..1dateThis is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)
.... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
...... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
...... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
...... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
...... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... PackageItem_Container 1..*BackboneElement9.6.2.3
..... PackageItem_ContainerType 1..1CodeableConceptThe package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)
..... PackageItem_ContainerQuantity 1..1QuantityThe quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)
..... Material 1..*CodeableConceptThe material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)
..... AlternateMaterial 0..*CodeableConceptThe alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)
..... DataCarrierIdentifier 0..*BackboneElement9.6.2.4
...... CodeSystem 1..1CodeableConceptThe data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)
...... Value 1..1CodeableConceptThe individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)
..... Device 0..*BackboneElement9.6.2.12
...... DeviceType 1..1CodeableConceptThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
...... DeviceTradeName 0..1stringThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
...... DeviceQuantity 1..1QuantityThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
...... DeviceListingNumber 0..1stringThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
...... DeviceIdentifier 0..1IdentifierA unique device identifier needs to be specified. (9.6.2.12.6)
...... ModelNumber 0..1stringThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
...... SterilityIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
...... SterilisationRequirementIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
...... DeviceUsage 0..1CodeableConceptThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
...... DeviceBatchIdentifier 0..*BackboneElement11.12
....... BatchNumber 1..1stringWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
....... ExpirationDate 1..1dateWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
...... DeviceMaterial 0..*BackboneElement9.6.2.13
....... Substance 1..1CodeableConceptThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
....... Alternate 0..1booleanThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
....... AllergenicIndicator 0..1booleanThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
...... DeviceNomenclature 0..*BackboneElement11.11
....... CodeSystem 1..1CodeableConceptThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
....... Value 1..1CodeableConceptThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
...... Manufacturer-Establishment_Organisation 0..1BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... OtherCharacteristics 0..*BackboneElement9.6.2.22
....... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
....... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
...... ShelfLife-Storage 0..*BackboneElement9.6.2.11
....... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
....... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
....... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
..... ManufacturedItem 0..*BackboneElement9.6.2.20
...... ManufacturedDoseForm 1..1CodeableConceptThis describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)
...... UnitOfPresentation 0..1CodeableConceptThis specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)
...... ManufacturedItemQuantity 1..1QuantityThe quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)
...... Ingredient 1..*BackboneElement11.2.9
....... IngredientRole 1..1CodeableConceptThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
....... AllergenicIndicator 0..1booleanThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
....... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
........ Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
......... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
......... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
......... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
......... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
.......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
.......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
.......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
.......... Contact 1..*BackboneElement9.4.2.4
........... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
.......... OtherLocations 0..*BackboneElement9.4.2.3
........... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... SpecifiedSubstance 0..*BackboneElement9.7.2.4
........ SpecifiedSubstance 1..1CodeableConceptWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
........ SpecifiedSubstanceGroup 1..1CodeableConceptThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
........ Strength 0..*BackboneElement9.7.2.5
......... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
......... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
......... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
......... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
......... ReferenceStrength 0..*BackboneElement9.7.2.6
.......... ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
.......... ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
.......... ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
.......... ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
.......... ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
....... Substance 0..1BackboneElement9.7.2.3
........ Substance 1..1CodeableConceptA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
........ Strength 1..*BackboneElement9.7.2.5
......... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
......... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
......... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
......... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
......... ReferenceStrength 0..*BackboneElement9.7.2.6
.......... ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
.......... ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
.......... ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
.......... ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
.......... ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
...... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... OtherCharacteristics 0..*BackboneElement9.6.2.22
....... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
....... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... OtherCharacteristics 0..*BackboneElement9.6.2.22
...... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
...... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
..... Package_Component 0..*BackboneElement9.6.2.9
...... ComponentType 1..1CodeableConceptThe type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)
...... ComponentMaterial 0..*CodeableConceptThe material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)
...... ComponentAlternateMaterial 0..*CodeableConceptAlternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)
...... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... PhysicalCharacteristics 0..1BackboneElement11.13
...... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
...... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
...... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
...... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
...... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
...... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
...... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
...... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
...... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
...... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
...... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... ShelfLife-Storage 0..*BackboneElement9.6.2.11
...... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
...... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
...... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
.... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
.... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
.... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
.... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
.... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
.... Contact 1..*BackboneElement9.4.2.4
..... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
..... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
..... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
.... OtherLocations 0..*BackboneElement9.4.2.3
..... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
..... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
..... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
..... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
..... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
..... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
..... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
..... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
... OrphanDesignation 0..*BackboneElement9.2.2.3
.... OrphanIndicationType 1..1CodeableConceptThis attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)
.... OrphanProcedureNumber 0..1IdentifierThis attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)
.... OrphanDesignationAuthorisationStatus 1..1CodeableConceptThis attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)
.... OrphanDesignationAuthorisationDate 0..1dateThis attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)
.... OrphanDesignationNumber 0..1IdentifierThis field is to indicate the orphan designation decision number. (9.2.2.3.6)
... PharmaceuticalProduct 1..*BackboneElement11.7.2
.... AdministrableDoseForm 1..1CodeableConceptThis shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)
.... UnitOfPresentation 0..1CodeableConceptThe unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)
.... Device 0..*BackboneElement9.6.2.12
..... DeviceType 1..1CodeableConceptThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
..... DeviceTradeName 0..1stringThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
..... DeviceQuantity 1..1QuantityThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
..... DeviceListingNumber 0..1stringThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
..... DeviceIdentifier 0..1IdentifierA unique device identifier needs to be specified. (9.6.2.12.6)
..... ModelNumber 0..1stringThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
..... SterilityIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
..... SterilisationRequirementIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
..... DeviceUsage 0..1CodeableConceptThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
..... DeviceBatchIdentifier 0..*BackboneElement11.12
...... BatchNumber 1..1stringWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
...... ExpirationDate 1..1dateWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
..... DeviceMaterial 0..*BackboneElement9.6.2.13
...... Substance 1..1CodeableConceptThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
...... Alternate 0..1booleanThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
...... AllergenicIndicator 0..1booleanThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
..... DeviceNomenclature 0..*BackboneElement11.11
...... CodeSystem 1..1CodeableConceptThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
...... Value 1..1CodeableConceptThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
..... Manufacturer-Establishment_Organisation 0..1BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... OtherCharacteristics 0..*BackboneElement9.6.2.22
...... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
...... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
..... PhysicalCharacteristics 0..1BackboneElement11.13
...... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
...... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
...... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
...... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
...... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
...... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
...... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
...... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
...... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
...... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
...... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... ShelfLife-Storage 0..*BackboneElement9.6.2.11
...... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
...... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
...... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
.... DosingAndRouteOfAdministration 1..*BackboneElement11.7.3
..... RouteOfAdministration 1..1CodeableConcept (11.7.3.0)
..... FirstDoseInHumans 0..1QuantityThe first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2)
..... MaximumSingleDose 0..1QuantityThe maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3)
..... MaximumDosePerDay 0..1QuantityThe maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4)
..... MaximumDosePerTreatmentPeriod 0..1RatioThe maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5)
..... MaximumTreatmentPeriod 0..1QuantityThe maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6)
.... Ingredient 1..*BackboneElement11.2.9
..... IngredientRole 1..1CodeableConceptThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
..... AllergenicIndicator 0..1booleanThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
..... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... SpecifiedSubstance 0..*BackboneElement9.7.2.4
...... SpecifiedSubstance 1..1CodeableConceptWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
...... SpecifiedSubstanceGroup 1..1CodeableConceptThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
...... Strength 0..*BackboneElement9.7.2.5
....... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
....... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
....... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
....... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
....... ReferenceStrength 0..*BackboneElement9.7.2.6
........ ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
........ ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
........ ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
........ ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
........ ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
..... Substance 0..1BackboneElement9.7.2.3
...... Substance 1..1CodeableConceptA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
...... Strength 1..*BackboneElement9.7.2.5
....... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
....... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
....... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
....... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
....... ReferenceStrength 0..*BackboneElement9.7.2.6
........ ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
........ ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
........ ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
........ ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
........ ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
.... PharmaceuticalProductCharacteristics 0..*BackboneElement9.8.2.4
..... CodeSystem 1..1CodeableConceptThe code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)
..... Value 1..1CodeableConceptThe individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)
..... Status 0..1CodeableConceptThe status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)
.... PhPIDSet 1..*BackboneElement9.8.2.6
..... PhPIDIdentifierSets 1..1IdentifierThis class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)
... ProductClassification 0..*BackboneElement11.3.2.7
.... CodeSystem 1..1CodeableConceptThe Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)
.... Value 1..1CodeableConceptThe individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)
... ProductCross-Reference 0..*BackboneElement11.3.2.4
.... I_MPIDCross-Reference 1..1IdentifierThis is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)
.... ReferencedProductType 0..1CodeableConceptThis attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)
... TherapeuticIndication 1..*BackboneElement9.9.2.2
.... IndicationText 1..1stringThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
.... IndicationAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
.... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
.... Comorbidity 0..*CodeableConceptIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
.... IntendedEffect 0..1CodeableConceptThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
.... Timing-Duration 0..1QuantityIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
.... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
..... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
..... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
.... PopulationSpecifics 1..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
.... UndesirableEffects 0..*BackboneElement9.9.2.4
..... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
..... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
..... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
..... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
..... PopulationSpecifics 0..*BackboneElement9.9.2.5
...... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
...... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
...... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
...... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
...... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
...... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
... UndesirableEffects 0..*BackboneElement9.9.2.4
.... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
.... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
.... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
.... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
.... PopulationSpecifics 0..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. InvestigationalMedicinalProduct 0..*
... IMPID 1..1IdentifierThe identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2)
... CombinedPharmaceuticalDoseForm 0..1CodeableConceptThe combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3)
... SponsorProductCode 0..1stringThe product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4)
... PaediatricUseIndicator 0..1CodeableConceptIf the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6)
... ClinicalTrialStatus 0..1CodeableConceptThe status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7)
... OrphanDesignationStatus 0..1CodeableConceptSee 9.2.2.2.7 . (11.3.2.2.8)
... AttachedDocument 1..*BackboneElement11.3.2.6
.... Identifier 1..1IdentifierThe reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)
.... EffectiveDate 1..1dateThe date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)
.... Type 1..1CodeableConceptThe type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)
.... Content 1..1base64BinaryThe actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)
.... Language 0..1CodeableConceptThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)
.... MediaType 0..1CodeableConceptThis attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)
.... VersionNumber 0..1stringThis is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)
.... VersionSetIdentifier 0..1IdentifierThis is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)
... ClinicalTrialAuthorisation 1..*BackboneElement11.4.2.2
.... RegistrationNumber 1..1IdentifierThe registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2)
.... InvestigationCode 1..1stringThe code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3)
.... Country 1..*CodeableConceptThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4)
.... ProtocolNumber 1..1IdentifierThe number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5)
.... AuthorisationDate 1..1dateThe date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6)
.... AnticipatedEndDate 1..1dateThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7)
.... LocalClinicalTrialAuthorisation 0..*BackboneElement11.4.2.3
..... LocalClinicalTrialRegistrationNumber 1..1IdentifierThe registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2)
..... LocalInvestigationCode 1..1stringThe “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3)
..... Jurisdiction 1..*CodeableConceptThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4)
..... LocalAuthorisationDate 1..1dateThe date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5)
..... LocalAnticipatedEndDate 1..1dateThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6)
.... MedicinesRegulatoryAgency_Organisation 1..1BackboneElement9.3.2.5
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... Sponsor_Organisation 1..1BackboneElement11.4.2.4
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... SME 0..1BackboneElement9.3.2.4
...... SMEFlag 1..1booleanThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
...... Size 0..1CodeableConceptThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
...... SMENumber 0..1IdentifierThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
...... StatusDate 0..1dateThis is the date when the SME status was granted. (9.3.2.4.4)
... Contraindication 0..*BackboneElement9.9.2.3
.... ContraindicationsText 1..1stringThe text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)
.... ContraindicationsAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)
.... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)
.... Comorbidity 0..*CodeableConceptThe comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)
.... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
..... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
..... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
.... PopulationSpecifics 0..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
.... TherapeuticIndication 0..*BackboneElement9.9.2.2
..... IndicationText 1..1stringThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
..... IndicationAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
..... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
..... Comorbidity 0..*CodeableConceptIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
..... IntendedEffect 0..1CodeableConceptThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
..... Timing-Duration 0..1QuantityIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
..... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
...... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
...... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
..... PopulationSpecifics 1..*BackboneElement9.9.2.5
...... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
...... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
...... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
...... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
...... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
...... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
..... UndesirableEffects 0..*BackboneElement9.9.2.4
...... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
...... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
...... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
...... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
...... PopulationSpecifics 0..*BackboneElement9.9.2.5
....... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
....... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
....... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
....... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
....... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
....... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
... Header 1..1BackboneElement11.3.2.5
.... Identifier 1..1IdentifierThis attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)
.... EffectiveDate 1..1dateThe date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)
.... Language 0..1CodeableConceptThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)
.... VersionNumber 0..1stringThis is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)
.... VersionSetIdentifier 0..1IdentifierThis is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)
... Interactions 0..*BackboneElement9.9.2.7
.... InteractionsText 1..1stringThe text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)
.... Interactant 0..*CodeableConceptThis element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)
.... InteractionsType 0..1CodeableConceptThe type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)
.... InteractionsEffect 0..1CodeableConceptThe effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)
.... InteractionsIncidence 0..1CodeableConceptThe incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)
.... ManagementActions 0..1CodeableConceptThe actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)
... InvestigationalMedicinalProductName 1..1BackboneElement11.3.2.8
.... FullName 0..1stringThe full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1)
.... Code 0..1stringThe Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2)
.... InventedNamePart 0..*stringThe invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)
.... ScientificNamePart 0..*stringThe scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)
.... StrengthPart 0..*stringThe strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)
.... PharmaceuticalDoseFormPart 0..*stringThe pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)
.... FormulationPart 0..*stringThe formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)
.... IntendedUsePart 0..*stringThe intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)
.... TargetPopulationPart 0..*stringThe target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)
.... ContainerOrPackPart 0..*stringThe container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)
.... DevicePart 0..*stringThe device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)
.... TrademarkOrCompanyNamePart 0..*stringThe trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)
.... Time-PeriodPart 0..*stringThe time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)
.... FlavourPart 0..*stringThe flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)
.... DelimiterPart 0..*stringA delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)
.... Country-Language 1..*BackboneElement9.2.2.9
..... Country 1..1CodeableConceptThe country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)
..... Jurisdiction 0..1CodeableConceptThe jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)
..... Language 1..1CodeableConceptThe language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)
... InvestigationalPackagedMedicinalProduct 0..*BackboneElement11.2.7
.... IPCID 1..1IdentifierThis is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)
.... PackageDescription 1..1stringA textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)
.... BatchIdentifier 0..*BackboneElement9.6.2.8
..... BAID1 1..1IdentifierThe BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)
..... BAID2 0..1IdentifierThe BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)
..... ExpirationDate 1..1dateThis is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)
.... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
..... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
..... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
..... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
..... Contact 1..*BackboneElement9.4.2.4
...... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
...... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
...... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
..... OtherLocations 0..*BackboneElement9.4.2.3
...... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
...... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
...... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
...... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
...... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
...... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
...... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
...... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... PackageItem_Container 1..*BackboneElement9.6.2.3
..... PackageItem_ContainerType 1..1CodeableConceptThe package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)
..... PackageItem_ContainerQuantity 1..1QuantityThe quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)
..... Material 1..*CodeableConceptThe material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)
..... AlternateMaterial 0..*CodeableConceptThe alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)
..... DataCarrierIdentifier 0..*BackboneElement9.6.2.4
...... CodeSystem 1..1CodeableConceptThe data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)
...... Value 1..1CodeableConceptThe individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)
..... Device 0..*BackboneElement9.6.2.12
...... DeviceType 1..1CodeableConceptThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
...... DeviceTradeName 0..1stringThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
...... DeviceQuantity 1..1QuantityThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
...... DeviceListingNumber 0..1stringThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
...... DeviceIdentifier 0..1IdentifierA unique device identifier needs to be specified. (9.6.2.12.6)
...... ModelNumber 0..1stringThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
...... SterilityIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
...... SterilisationRequirementIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
...... DeviceUsage 0..1CodeableConceptThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
...... DeviceBatchIdentifier 0..*BackboneElement11.12
....... BatchNumber 1..1stringWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
....... ExpirationDate 1..1dateWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
...... DeviceMaterial 0..*BackboneElement9.6.2.13
....... Substance 1..1CodeableConceptThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
....... Alternate 0..1booleanThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
....... AllergenicIndicator 0..1booleanThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
...... DeviceNomenclature 0..*BackboneElement11.11
....... CodeSystem 1..1CodeableConceptThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
....... Value 1..1CodeableConceptThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
...... Manufacturer-Establishment_Organisation 0..1BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... OtherCharacteristics 0..*BackboneElement9.6.2.22
....... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
....... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
...... ShelfLife-Storage 0..*BackboneElement9.6.2.11
....... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
....... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
....... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
..... ManufacturedItem 0..*BackboneElement9.6.2.20
...... ManufacturedDoseForm 1..1CodeableConceptThis describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)
...... UnitOfPresentation 0..1CodeableConceptThis specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)
...... ManufacturedItemQuantity 1..1QuantityThe quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)
...... Ingredient 1..*BackboneElement11.2.9
....... IngredientRole 1..1CodeableConceptThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
....... AllergenicIndicator 0..1booleanThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
....... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
........ Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
......... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
......... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
......... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
......... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
.......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
.......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
.......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
.......... Contact 1..*BackboneElement9.4.2.4
........... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
.......... OtherLocations 0..*BackboneElement9.4.2.3
........... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... SpecifiedSubstance 0..*BackboneElement9.7.2.4
........ SpecifiedSubstance 1..1CodeableConceptWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
........ SpecifiedSubstanceGroup 1..1CodeableConceptThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
........ Strength 0..*BackboneElement9.7.2.5
......... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
......... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
......... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
......... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
......... ReferenceStrength 0..*BackboneElement9.7.2.6
.......... ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
.......... ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
.......... ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
.......... ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
.......... ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
....... Substance 0..1BackboneElement9.7.2.3
........ Substance 1..1CodeableConceptA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
........ Strength 1..*BackboneElement9.7.2.5
......... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
......... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
......... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
......... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
......... ReferenceStrength 0..*BackboneElement9.7.2.6
.......... ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
.......... ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
.......... ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
.......... ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
.......... ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
...... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... OtherCharacteristics 0..*BackboneElement9.6.2.22
....... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
....... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... OtherCharacteristics 0..*BackboneElement9.6.2.22
...... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
...... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
..... Package_Component 0..*BackboneElement9.6.2.9
...... ComponentType 1..1CodeableConceptThe type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)
...... ComponentMaterial 0..*CodeableConceptThe material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)
...... ComponentAlternateMaterial 0..*CodeableConceptAlternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)
...... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
....... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
....... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
....... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
....... Contact 1..*BackboneElement9.4.2.4
........ Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
........ Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
........ Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
....... OtherLocations 0..*BackboneElement9.4.2.3
........ LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
........ LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
........ LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
........ Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
....... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
........ OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
........ ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
........ EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
........ MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
......... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
......... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
......... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
......... Contact 1..*BackboneElement9.4.2.4
.......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
.......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
.......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
.......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
......... OtherLocations 0..*BackboneElement9.4.2.3
.......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
.......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
.......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
.......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
.......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... PhysicalCharacteristics 0..1BackboneElement11.13
....... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
....... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
....... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
....... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
....... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
....... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
....... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
....... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
....... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
....... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
....... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... PhysicalCharacteristics 0..1BackboneElement11.13
...... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
...... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
...... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
...... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
...... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
...... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
...... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
...... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
...... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
...... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
...... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... ShelfLife-Storage 0..*BackboneElement9.6.2.11
...... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
...... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
...... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
.... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
.... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
.... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
.... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
.... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
.... Contact 1..*BackboneElement9.4.2.4
..... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
..... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
..... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
.... OtherLocations 0..*BackboneElement9.4.2.3
..... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
..... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
..... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
..... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
..... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
.... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
..... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
..... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
..... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
..... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
..... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
... OrphanDesignation 0..*BackboneElement9.2.2.3
.... OrphanIndicationType 1..1CodeableConceptThis attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)
.... OrphanProcedureNumber 0..1IdentifierThis attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)
.... OrphanDesignationAuthorisationStatus 1..1CodeableConceptThis attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)
.... OrphanDesignationAuthorisationDate 0..1dateThis attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)
.... OrphanDesignationNumber 0..1IdentifierThis field is to indicate the orphan designation decision number. (9.2.2.3.6)
... PharmaceuticalProduct 1..*BackboneElement11.7.2
.... AdministrableDoseForm 1..1CodeableConceptThis shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)
.... UnitOfPresentation 0..1CodeableConceptThe unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)
.... Device 0..*BackboneElement9.6.2.12
..... DeviceType 1..1CodeableConceptThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
..... DeviceTradeName 0..1stringThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
..... DeviceQuantity 1..1QuantityThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
..... DeviceListingNumber 0..1stringThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
..... DeviceIdentifier 0..1IdentifierA unique device identifier needs to be specified. (9.6.2.12.6)
..... ModelNumber 0..1stringThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
..... SterilityIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
..... SterilisationRequirementIndicator 0..1CodeableConceptWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
..... DeviceUsage 0..1CodeableConceptThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
..... DeviceBatchIdentifier 0..*BackboneElement11.12
...... BatchNumber 1..1stringWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
...... ExpirationDate 1..1dateWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
..... DeviceMaterial 0..*BackboneElement9.6.2.13
...... Substance 1..1CodeableConceptThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
...... Alternate 0..1booleanThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
...... AllergenicIndicator 0..1booleanThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
..... DeviceNomenclature 0..*BackboneElement11.11
...... CodeSystem 1..1CodeableConceptThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
...... Value 1..1CodeableConceptThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
..... Manufacturer-Establishment_Organisation 0..1BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... OtherCharacteristics 0..*BackboneElement9.6.2.22
...... CodeSystem 1..1CodeableConceptThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
...... Value 1..1CodeableConceptThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
..... PhysicalCharacteristics 0..1BackboneElement11.13
...... Height 0..1QuantityWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
...... Width 0..1QuantityWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
...... Depth 0..1QuantityWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
...... Weight 0..1QuantityWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
...... NominalVolume 0..1QuantityWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
...... ExternalDiameter 0..1QuantityWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
...... Shape 0..1stringWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
...... Colour 0..*stringWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
...... Imprint 0..*stringWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
...... Image 0..*base64BinaryWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
...... Scoring 0..1CodeableConceptWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
..... ShelfLife-Storage 0..*BackboneElement9.6.2.11
...... ShelfLifeType 1..1CodeableConceptThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
...... ShelfLifeTimePeriod 1..1QuantityThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
...... SpecialPrecautionsForStorage 0..*CodeableConceptSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
.... DosingAndRouteOfAdministration 1..*BackboneElement11.7.3
..... RouteOfAdministration 1..1CodeableConcept (11.7.3.0)
..... FirstDoseInHumans 0..1QuantityThe first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2)
..... MaximumSingleDose 0..1QuantityThe maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3)
..... MaximumDosePerDay 0..1QuantityThe maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4)
..... MaximumDosePerTreatmentPeriod 0..1RatioThe maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5)
..... MaximumTreatmentPeriod 0..1QuantityThe maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6)
.... Ingredient 1..*BackboneElement11.2.9
..... IngredientRole 1..1CodeableConceptThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
..... AllergenicIndicator 0..1booleanThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
..... Manufacturer-Establishment_Organisation 0..*BackboneElement9.5.2.2
...... Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
...... Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
...... Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
...... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
...... Contact 1..*BackboneElement9.4.2.4
....... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
....... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
....... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
...... OtherLocations 0..*BackboneElement9.4.2.3
....... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
....... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
....... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
....... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
....... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
...... Manufacturing-BusinessOperation 1..*BackboneElement9.5.2.3
....... OperationType 1..1CodeableConceptThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
....... ManufacturingAuthorisationReferenceNumber 0..1IdentifierThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
....... EffectiveDate 0..1dateThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
....... ConfidentialityIndicator 0..1CodeableConceptThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
....... MedicinesRegulatoryAgency_Organisation 0..1BackboneElement9.3.2.5
........ Identifier 1..1IdentifierThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
........ Name 1..1stringThe name of the organisation shall be provided in text. (9.4.2.2.3)
........ Address 1..1AddressThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
........ ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
........ GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
........ Contact 1..*BackboneElement9.4.2.4
......... Name 0..1HumanNameThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
......... Telecom 1..*ContactPointThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
......... Role 1..1CodeableConceptThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
......... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
........ OtherLocations 0..*BackboneElement9.4.2.3
......... LocationName 0..1stringThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
......... LocationAddress 1..1AddressThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
......... LocationRole 1..1CodeableConceptThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
......... Identifier 0..1IdentifierThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
......... GeographicCoordinates 0..1stringThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
..... SpecifiedSubstance 0..*BackboneElement9.7.2.4
...... SpecifiedSubstance 1..1CodeableConceptWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
...... SpecifiedSubstanceGroup 1..1CodeableConceptThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
...... ConfidentialityIndicator 0..1CodeableConceptThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
...... Strength 0..*BackboneElement9.7.2.5
....... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
....... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
....... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
....... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
....... ReferenceStrength 0..*BackboneElement9.7.2.6
........ ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
........ ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
........ ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
........ ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
........ ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
..... Substance 0..1BackboneElement9.7.2.3
...... Substance 1..1CodeableConceptA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
...... Strength 1..*BackboneElement9.7.2.5
....... Strength_Presentation 1..1RatioThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
....... Strength_Concentration 0..1RatioThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
....... MeasurementPoint 0..1stringThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
....... Country 0..*CodeableConceptThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
....... ReferenceStrength 0..*BackboneElement9.7.2.6
........ ReferenceSubstance 0..1CodeableConceptIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
........ ReferenceSpecifiedSubstance 0..1CodeableConceptIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
........ ReferenceStrength 1..1RatioThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
........ ReferenceStrengthMeasurementPoint 0..1stringThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
........ ReferenceStrengthCountry 0..*CodeableConceptWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
.... PharmaceuticalProductCharacteristics 0..*BackboneElement9.8.2.4
..... CodeSystem 1..1CodeableConceptThe code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)
..... Value 1..1CodeableConceptThe individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)
..... Status 0..1CodeableConceptThe status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)
.... PhPIDSet 1..*BackboneElement9.8.2.6
..... PhPIDIdentifierSets 1..1IdentifierThis class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)
... ProductClassification 0..*BackboneElement11.3.2.7
.... CodeSystem 1..1CodeableConceptThe Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)
.... Value 1..1CodeableConceptThe individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)
... ProductCross-Reference 0..*BackboneElement11.3.2.4
.... I_MPIDCross-Reference 1..1IdentifierThis is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)
.... ReferencedProductType 0..1CodeableConceptThis attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)
... TherapeuticIndication 1..*BackboneElement9.9.2.2
.... IndicationText 1..1stringThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
.... IndicationAsDisease-Symptom-Procedure 0..1CodeableConceptThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
.... DiseaseStatus 0..1CodeableConceptThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
.... Comorbidity 0..*CodeableConceptIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
.... IntendedEffect 0..1CodeableConceptThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
.... Timing-Duration 0..1QuantityIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
.... OtherTherapySpecifics 0..*BackboneElement9.9.2.6
..... TherapyRelationshipType 1..1CodeableConceptThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
..... Medication 1..1CodeableConceptReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
.... PopulationSpecifics 1..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
.... UndesirableEffects 0..*BackboneElement9.9.2.4
..... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
..... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
..... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
..... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
..... PopulationSpecifics 0..*BackboneElement9.9.2.5
...... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
...... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
...... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
...... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
...... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
...... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
... UndesirableEffects 0..*BackboneElement9.9.2.4
.... UndesirableEffectText 1..1stringThe text of the undesirable effect shall be given. (9.9.2.4.2)
.... UndesirableEffectAsSymptom-Condition-Effect 0..1CodeableConceptThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
.... Symptom-Condition-EffectClassification 0..1CodeableConceptThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
.... FrequencyOfOccurrence 0..1CodeableConceptThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
.... PopulationSpecifics 0..*BackboneElement9.9.2.5
..... Age 0..1CodeableConceptThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
..... AgeRangeLow 0..1QuantityThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
..... AgeRangeHigh 0..1QuantityThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
..... Gender 0..1CodeableConceptThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
..... Race 0..1CodeableConceptThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
..... PhysiologicalCondition 0..1CodeableConceptVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

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